Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04240002
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2020-01-21
Brief Title:
A Study of Gilteritinib ASP2215 Combined With Chemotherapy in Children Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 FLT3Internal Tandem Duplication ITD Positive Relapsed or Refractory Acute Myeloid Leukemia AML
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 12 Multicenter Open-Label Single Arm Dose Escalation and Expansion Study of Gilteritinib ASP2215 Combined With Chemotherapy in Children Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 FLT3Internal Tandem Duplication ITD Positive Relapsed or Refractory Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the phase 1 portion dose escalation of the study will be to establish an optimally safe and biologically active recommended phase 2 dose RP2D andor to determine maximum tolerated dose MTD for gilteritinib in sequential combination with fludarabine cytarabine and granulocyte colony-stimulating factor FLAG The purpose of the phase 2 portion dose expansion is to determine complete remission CR rates and composite complete remission CRc rates after two cycles of therapy The study will also assess safety tolerability and toxicities of gilteritinib in combination with FLAG evaluate FLT3 inhibition assess pharmacokinetics PK perform serial measurements of minimal residual disease obtain preliminary estimates of 1-year event free survival EFS and overall survival OS rate and assess the acceptability as well as palatability of the formulation
One cycle is defined as 28 days of treatment A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment LTT with gilteritinib for up to 2 years
One cycle is defined as 28 days of treatment A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment LTT with gilteritinib for up to 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002301-61 | EUDRACT_NUMBER | None | None |